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A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia

NCT03465787 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2023-02-08

No results posted yet for this study

Summary

This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.

Conditions

Interventions

DRUG

Lurasidone HCL 160 mg

Lurasidone HCL 2 80mg tablets, QD

DRUG

Quetiapine XR 600 mg

Quetiapine XR 2 300 mg tablets, QD

Sponsors & Collaborators

  • Bukwang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Jung Hee Yeon · SMG-SNU Boramae Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2022-10-26
Completion
2022-10-26

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03465787 on ClinicalTrials.gov